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灌胃黄芪水提物后犬血浆中 6 个成分的同时测定及药代动力学研究。

Simultaneous determination and pharmacokinetic study of six components in beagle dog plasma by UPLC-MS/MS after oral administration of Astragalus Membranaceus aqueous extract.

机构信息

Center for DMPK Research of Herbal Medicines, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China.

School of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.

出版信息

Biomed Chromatogr. 2022 Dec;36(12):e5488. doi: 10.1002/bmc.5488. Epub 2022 Sep 4.

Abstract

Astragalus Membranaceus (AM) is widely applied in Chinese herbal compound formulas for treating various kinds of diseases. However, relative pharmacokinetics data on AM in nonrodents is still lacking. Here, an UPLC-MS/MS method for determining the six main compounds of AM was developed. The chromatographic separation was carried out by a Waters Acquity UPLC HSS T3 column (100 × 2.1 mm, 1.8 μm) with gradient elution of water-formic acid (99.98:0.02, v/v) and acetonitrile-formic acid (99.98:0.02, v/v) at a flow rate of 0.3 ml/min within 11 min. Analyses of all compounds were conducted in multiple reaction monitoring mode with a positive/negative ion-switching mode of an electrospray ionization source in a single run. The analytical method was validated in terms of specificity, linearity, accuracy, precision, stability, etc. The method showed excellent linearity (r > 0.999) over certain concentration ranges. The intra-day and inter-day precisions were evaluated, and the RSD values were <12.4%. Furthermore, the validated method was successfully applied to determine the six components in plasma after oral administration of AM aqueous extract to beagle dogs and the pharmacokinetic parameters were obtained. Together, this study provides a reference for medication in the clinical practice of AM.

摘要

黄芪(AM)广泛应用于中药复方制剂治疗各种疾病。然而,非啮齿类动物中关于 AM 的相对药代动力学数据仍然缺乏。本研究建立了一种同时测定 AM 中 6 种主要成分的 UPLC-MS/MS 方法。采用 Waters Acquity UPLC HSS T3 柱(100×2.1mm,1.8μm)进行色谱分离,以水-甲酸(99.98:0.02,v/v)和乙腈-甲酸(99.98:0.02,v/v)为流动相,梯度洗脱,流速为 0.3ml/min,在 11min 内完成洗脱。所有化合物均采用电喷雾电离源正/负离子切换模式,在单次运行中以多反应监测模式进行分析。该方法在专属性、线性、准确度、精密度、稳定性等方面进行了验证。该方法在一定浓度范围内具有良好的线性(r>0.999)。日内和日间精密度均得到评估,RSD 值<12.4%。此外,该验证方法成功应用于测定口服 AM 水提物后比格犬血浆中 6 种成分的含量,并获得了药代动力学参数。综上所述,本研究为 AM 的临床应用提供了参考。

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